BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVUS S5IX IMAGING SYSTEM

    MDR report key: 1301930 · Received February 2, 2009

    Report

    Report Number
    MW5009785
    Event Type
    Malfunction
    Date Received
    February 2, 2009
    Date of Event
    January 8, 2009
    Report Date
    January 19, 2009
    Manufacturer
    VOLCANO CORP
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    USER IN CATH LAB CALLED VENDOR FOR TECH SUPPORT REGARDING CONTROL PANEL FOR VOLCANO IVUS S5I IMAGING SYSTEM IN CATH LAB B. VENDOR INFORMED USER THAT PROBLEM WAS CAUSED BY SOFTWARE, AND SCHEDULED A TIME FOR ONSITE SERVICE. IN EARLY 2009, CLINICAL PERSONNEL FROM VENDOR ARRIVED AT HOSPITAL TO TRAIN CARDIO VASCULAR TECHS ON OPERATION OF NEW SOFTWARE. TWO DAYS LATER, FIELD ARRIVED ON SITE FOR SOFTWARE AND HARDWARE UPGRADE, AND REQUESTED ASSISTANCE FROM BIOMEDICAL ENGINEERING PERSONNEL. BIOMED ATTEMPTED TO CONTACT FACILITIES ENGINEERING BECAUSE VENDOR CLAIMED TO NEED TO PULL CABLES FROM GROUND AND CEILING. BIOMED INFORMED FSE THAT OUR POLICY RESTRICTS VENDORS FROM PULLING THEIR OWN CABLES, TO WHICH HE RESISTED. NONETHELESS, VENDOR WAS ALLOWED TO PULL THE CABLES WITH ASSISTANCE. THE FOLLOWING DAY, BIOMED WAS INFORMED THAT CATH LAB B WAS STILL DOWN. AT AROUND 1PM, BIOMED WAS INFORMED THAT CONTROL BOARD WAS DEFECTIVE AND NEEDED TO BE REPLACED. BIOMED EXPRESSED DISAPPOINTMENT WITH SERVICE RECEIVED FROM COMPANY, AND THE UNNECESSARY TIME SPENT PULING CABLES AND UPGRADING SOFTWARE WHICH DID NOT FIX THE INITIAL COMPLAINT ABOUT THE DEFECTIVE CONTROL BOARD. BIOMED ENCOUNTERED FURTHER ISSUES WITH ORDERING A REPLACEMENT AS IT TOOK THREE HOURS TO ACQUIRE A PART NUMBER AND PRICE QUOTE FROM THE VENDOR. THE PART WAS EVENTUALLY ORDERED AT A COST. ON 01/19/2009, BIOMED ENTERED CATH LAB B TO INSTALL THE NEW CONTROL BOARD. BEFORE DOING GO, BIOMED DECIDED TO RUN SOME TESTS ON THE BOARD BEING REPLACED. BIOMED REALIZED THAT THE CONTROL BOARD WAS NOT DEFECTIVE, RATHER AN ATTACHED KEYBOARD WAS SLIGHTLY DEFECTIVE, BUT COULD NOT CORRECT BY RESEATING A RIBBON CABLE CONNECTING KEYBOARD TO CONTROL BOARD. BIOMED FELT THAT THE RIBBON CABLE IS TOO SHORT AND WEAK, AND MAY CAUSE FURTHER ISSUES EVEN IN THE NEWLY PURCHASED CONTROL BOARD. BIOMED CONTACTED TECHNICAL SERVICE AT VOLCANO TO REGISTER THIS COMPLAINT, AND ATTEMPT TO FIND AN ALTERNATIVE SOLUTION. BIOMED SPOKE WITH DIRECTOR OF TECHNICAL SERVICE, WHO REFUSED TO REGISTER A CUSTOMER COMPLAINT AND REMEDY THE SITUATION. AFTER SEVERAL ATTEMPTS, RN, THE CLINICAL CONSULTANT FOR CONTACTED BIOMED AND INFORMED US THAT HE HAD SPOKEN WITH SETH WHO AGREED TO SEND TWO RIBBON CABLES TO ATTEMPT A REPAIR ON THE OLD CONTROL BOARD. HE ACKNOWLEDGED THAT THIS RIBBON CABLE IS SHORT AND WEAK, AND WARNED THAT WE SHOULD BE MORE CAREFUL WHEN PULLING THE KEYBOARD OUT. BIOMED HAS WARNED THE STAFF, AND RECOMMENDS VENDOR USE LONGER AND STRONGER RIBBON CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVUS S5IX IMAGING SYSTEM IVUS DQO VOLCANO CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other